Based On The Clinical Safety Evaluation Of New Drug Of Tcm Terms Meddra Coding Database Research

Objective:In this study, we use the research methods of the generic term coding dictionaries, reference to the World Health Organization adverse reaction terminology (WHO-ART) coding, Drug Dictionary (WHO-Drug Dictionary), and MedDRA term set. We add several things connect the Chinese medicine, fully maintain the original terms of Chinese medicine. However, its specification of collection methods and terminology connotation is depict in modern language interpretation in order to establish the terminology standardized database of Chinese medicine clinical trial safety evaluation and dock with the clinical trial safety data management software. We try to establish timely and accurate observation of clinical safety data of the Chinese Drug Research and data analysis of the safety evaluation technology platforms.Process:1. Reviewed connected papers to understand Chinese materia medica adverse reactions and the regulation of adverse drug reactions in U. S. FDA and Chinese GCP. The general medical standardized terminology set was also reviewed.2. We introduced the MedDRA terminology set to our process, analyzed its contents, the hierarchical structure, coding principles and application.3. In this study, we compared the difference between the nouns of TCM symptoms referred in the book 《Chinese Terms in Traditional Chinese Medicine and Pharmacy》(Science Publishing House in2004) which is written by Traditional Chinese Medicine Terminology Committee and published by National Science and Technology Terminology Committee with MedDRA,a total of443nouns.4. We used MedDRA terminology set as a reference and basis, added the three types of nouns according to Chinese medicine standard language and MedDRA difference results to the MedDRA terminology set in order to expand it. A total increase contains:1SOC,6HLGT,60LGT,90PT, and205LLT. We added the particular Chinese medicine meaning terms, established of the initial new coding database.Conclusion:With the form of data management software, we installed a traditional Chinese medicine terminology standardization of clinical trials database, the international medical terminology dictionary MedDRA, and traditional Chinese medicine clinical safety evaluation terminology coding database into the software. Preliminary established the Traditional Chinese Drug clinical safety evaluation platform. This built the basis for sharing and international mutual recognition of the disease clinical trial data. And we also connected it with the clinical trial safety data management software. The technology platform of the safety evaluation has ability to Observe and analyse the clinical safety data of the Chinese materia medica Research.